RETROVIR ORAL SOLUTION

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

ZIDOVUDINE

متاح من:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC رمز:

J05AF01

الشكل الصيدلاني:

SOLUTION

تركيب:

ZIDOVUDINE 10 MG/ML

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

VIIV HEALTHCARE UK LIMITED, UK

المجال العلاجي:

ZIDOVUDINE

الخصائص العلاجية:

Retrovir oral formulations are indicated in anti-retroviral combination therapy for Human Immunodeficiency Virus (HIV) infected adults and children.Retrovir chemoprophylaxis is indicated for use in HIV-positive pregnant women (over 14 weeks of gestation) for prevention of maternal-foetal HIV transmission and for primary prophylaxis of HIV infection in newborn infants.

تاريخ الترخيص:

2023-02-28

نشرة المعلومات

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed according to a physician’s prescription
only
Retrovir Oral Solution
Each 1 ml of oral solution contains 10 mg zidovudine.
For the list of the inactive and allergenic ingredients in the
medicine, see section
2 – “
Important information about some of the ingredients in the medicine
” and
section 6 – “Additional information”.
Read the leaflet carefully in its entirety before using the medicine.
This leaflet
contains concise information about the medicine. If you have further
questions,
refer to the physician or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them, even if it seems to you that their medical condition is
similar.
1.
WHAT IS THE MEDICINE INTENDED FOR?
Retrovir is used, together with additional anti-retroviral medicines,
to treat adults
and children infected with human immunodeficiency virus (HIV).
Preventive treatment with Retrovir is indicated for pregnant and
HIV-positive
women (after the 14th week of pregnancy) to prevent intrauterine
infection of the
fetus and for primary prevention of HIV infection in a newborn baby.
Therapeutic group: The active ingredient in Retrovir is zidovudine.
Retrovir
belongs to a group of medicines called
nucleoside analogue reverse
transcriptase inhibitors (NRTIs)
.
Retrovir does not eliminate the HIV infection; it reduces the amount
of virus in
your body, and keeps it at a low level. Retrovir increases the
CD4 cell count
in
your blood.
CD4
cells are a type of white blood cells that are important in helping
your body to fight infection.
HIV infection is spread by sexual contact with someone who is infected
or by
transfer of infected blood (for example, when sharing injection
needles).
2.
BEFORE USING THE MEDICINE
Do not use the medicine if:
• you are sensitive (allergic) to zidovudine or to any of the
additional
ingredients contained in this medicine (listed in section 6).
• you have a

خصائص المنتج

Page
1
of
15
1.
NAME OF THE MEDICINAL PRODUCT
Retrovir oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
10 ml of solution contains 100 mg zidovudine.
Excipient(s) with known effect:
10 ml of solution contains 6.4 g of maltitol
10 ml of solution contains 20 mg of sodium benzoate
10 ml of solution contains 96 mg of propylene glycol
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Retrovir 100 mg/10ml oral solution.
A clear, pale yellow, strawberry-flavoured, sugar-free oral solution.
The pack contains an oral-dosing syringe which should be fitted to the
bottle before use.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Retrovir oral formulations are indicated in anti-retroviral
combination therapy for Human
Immunodeficiency Virus (HIV) infected adults and children.
Retrovir chemoprophylaxis is indicated for use in HIV-positive
pregnant women (over 14
weeks of gestation) for prevention of maternal-foetal HIV transmission
and for primary
prophylaxis of HIV infection in newborn infants.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Retrovir should be prescribed by physicians who are experienced in the
treatment of HIV
infection.
_Dosage in adults and adolescents weighing at least 30 kg: _
The usual recommended dose of
Retrovir in combination with other anti-retroviral agents is 250 or
300 mg twice daily.
_Dosage in children:_
Retrovir 100 mg capsules are also available for use in children.
_ _
_Children weighing at least 9 kg and less than 30 kg: _
The recommended dose of Retrovir is
0.9 mL/kg (9 mg/kg) twice daily in combination with other
antiretroviral agents (e.g. a 15 kg
child would require a 13.5 mL dose of oral solution twice daily). The
maximum dosage
should not exceed 300 mg (30 mL) twice daily.
_Children weighing at least 4 kg and less than 9 kg:_
The recommended dose of Retrovir is
1.2 mL/kg (12 mg/kg) twice daily in combination with other
antiretroviral agents (e.g. a 5 kg
neonate would require a 6 mL dose of oral solution twice daily).
Page
2
of
15
Available data are insuffi